ChiCTR2000032495 版本V1.0 版本创建时间2020/04/30 12:15:18 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000032495 

最近更新日期：

Date of Last Refreshed on：

 2020-04-30 12:15:07 

注册时间：

Date of Registration：

 2020-04-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children:&

Public title：

Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children:&

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children:&

Scientific title：

Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children: A Pilot Randomized Controlled Trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Shu-Cheng CHEN 

研究负责人：

Wing-Fai YEUNG 

Applicant：

Shu-Cheng CHEN 

Study leader：

Wing-Fai YEUNG 

申请注册联系人电话：

Applicant telephone：

 +85267653381

研究负责人电话：

Study leader's
telephone：

+85227664151

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 shucheng.chen@connect.polyu.hk

研究负责人电子邮件：

Study leader's E-mail：

 jerry-wf.yeung@polyu.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, China

研究负责人通讯地址：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, China

Applicant address：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, China

Study leader's address：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

 999077

研究负责人邮政编码：

Study leader's postcode：

 999077

申请人所在单位：

香港理工大學

Applicant's institution：

The Hong Kong Polytechnic University

研究负责人所在单位：

香港理工大學

Affiliation of the Leader：

The Hong Kong Polytechnic University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 HSEARS20190824002

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Departmental Research Committee (on behalf of Human Subjects Ethics Sub-Committee)

Name of the ethic committee：

Departmental Research Committee (on behalf of Human Subjects Ethics Sub-Committee)

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

CHOI Kup Sze (Thomas)

Contact Name of the ethic committee：

CHOI Kup Sze (Thomas)

伦理委员会联系地址：

School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, China

Contact Address of the ethic committee：

School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

香港理工大學

Primary sponsor：

The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

Hung Hom, Kowloon, Hong Kong, China

Primary sponsor's address：

Hung Hom, Kowloon, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Hong Kong

City：

Kowloon

单位(医院)：

具体地址：

Institution
hospital：

The Hong Kong Polytechnic University

Address：

Hung Hom, Kowloon, Hong Kong, China

经费或物资来源：

Associated money

Source(s) of funding：

Associated money

研究疾病：

Attention deficit hyperactivity disorder (ADHD)  

Target disease：

Attention deficit hyperactivity disorder (ADHD)

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To preliminarily assess the effects and feasibility of parent-delivered pediatric tuina for ADHD symptoms in preschool children for a further fully powered RCT.  

Objectives of Study：

To preliminarily assess the effects and feasibility of parent-delivered pediatric tuina for ADHD symptoms in preschool children for a further fully powered RCT.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria for the children are:
(1) children between 3-7 years old by the time of the start of the assessment;
Children with ADHD symptoms of hyperactivity, anxiety, or inattention will be recruited in this study.
Inclusion criteria for parents are:
(1) able to communicate using Mandarin;
(2) willing to learn the knowledge and manipulations of TCM pediatric massage for treating ADHD;
(3) available to take their child to hospital for treatment and conduct manipulations at home according to the study process;
(4) agree to give informed consent.

Inclusion criteria

Inclusion criteria for the children are:
(1) children between 3-7 years old by the time of the start of the assessment;
Children with ADHD symptoms of hyperactivity, anxiety, or inattention will be recruited in this study.
Inclusion criteria for parents are:
(1) able to communicate using Mandarin;
(2) willing to learn the knowledge and manipulations of TCM pediatric massage for treating ADHD;
(3) available to take their child to hospital for treatment and conduct manipulations at home according to the study process;
(4) agree to give informed consent.

排除标准：

Exclusion criteria for children are:
(1) currently receiving other massage therapy;
(2) having other developmental disability such as autism spectrum disorders or intellectual disability;
(3) having acute infection diseases (such as scarlet fever, chickenpox), hemorrhagic diseases (like bleeding, local places of various kinds of malignant tumor), or dermatological problems (e.g. scald, severe skin lesion, or skin infections);
(4) having any severe illness or medical condition that the investigator deems not appropriate to receive TCM massage (e.g. bone fractures and paraplegia).
Exclusion criteria for parents are:
(1) having any severe psychiatric disorder, such as major depressive disorder;
(2) having difficulties to conduct massage therapy due to physical problems;
(3) having a score of Montreal Cognitive Assessment (MoCA) less than 22, indicating cognitive impairment (Appendix 1: Montreal Cognitive Assessment (MoCA) – Chinese Version)

Exclusion criteria：

Exclusion criteria for children are:
(1) currently receiving other massage therapy;
(2) having other developmental disability such as autism spectrum disorders or intellectual disability;
(3) having acute infection diseases (such as scarlet fever, chickenpox), hemorrhagic diseases (like bleeding, local places of various kinds of malignant tumor), or dermatological problems (e.g. scald, severe skin lesion, or skin infections);
(4) having any severe illness or medical condition that the investigator deems not appropriate to receive TCM massage (e.g. bone fractures and paraplegia).
Exclusion criteria for parents are:
(1) having any severe psychiatric disorder, such as major depressive disorder;
(2) having difficulties to conduct massage therapy due to physical problems;
(3) having a score of Montreal Cognitive Assessment (MoCA) less than 22, indicating cognitive impairment (Appendix 1: Montreal Cognitive Assessment (MoCA) – Chinese Version)

研究实施时间：

Study execute time：

从 From 2020-05-31 00:00:00至 To 2021-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-05-31 00:00:00 至 To 2020-10-31 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 30

Group：

Experimental group

Sample size：

干预措施：

Pediatric tuina

干预措施代码：

Intervention：

Pediatric tuina

Intervention code：

组别：

Control group

样本量：

 30

Group：

Control group

Sample size：

干预措施：

Parent-child interaction

干预措施代码：

Intervention：

Parent-child interaction

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 山東 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 山東中醫藥大學附屬醫院 

单位级别：

 三甲医院 

Institution
hospital：

Shandong University of Traditional Chinese Medicine Affiliated Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

Hyperactivity

指标类型：

主要指标

Outcome：

Hyperactivity

Type：

Primary indicator

测量时间点：

Baseline, week 4, week 8

测量方法：

The self-completed Swanson, Nolan and Pelham Parent Scale (SNAP-IV-P) – Chinese Version

Measure time point of outcome：

Baseline, week 4, week 8

Measure method：

The self-completed Swanson, Nolan and Pelham Parent Scale (SNAP-IV-P) – Chinese Version

指标中文名：

Anxiety

指标类型：

次要指标

Outcome：

Anxiety

Type：

Secondary indicator

测量时间点：

Baseline, week 4, week 8

测量方法：

Preschool Anxiety Scale (PAS)

Measure time point of outcome：

Baseline, week 4, week 8

Measure method：

Preschool Anxiety Scale (PAS)

指标中文名：

Sleep disorders

指标类型：

次要指标

Outcome：

Sleep disorders

Type：

Secondary indicator

测量时间点：

Baseline, week 4, week 8

测量方法：

Children's Sleep Habits Questionnaire (CSHQ)

Measure time point of outcome：

Baseline, week 4, week 8

Measure method：

Children's Sleep Habits Questionnaire (CSHQ)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

NA

组织：

Sample Name：

NA

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 3 岁 years
最大 Max age 7 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Participants will be randomly assigned to either intervention group or active control group in a 1:1 ratio by a computer-generated randomization schedule using permuted blocks of random sizes.

Randomization Procedure (please state who generates the random number sequence and by what method)：

Participants will be randomly assigned to either intervention group or active control group in a 1:1 ratio by a computer-generated randomization schedule using permuted blocks of random sizes.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

ResMan临床试验公共管理平台

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

ResMan (www.medresman.org)

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Via www.chictr.org.cn

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Via www.chictr.org.cn

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-04-30 12:15:07